Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Dietary Supplement: Vitamin A

• Registration Number: NCT03039257
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.

Detailed Description

The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation.

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Study Start: 2017-02-02
• Primary Completion: 2018-01-17
• Study Completion: 2018-03-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Any patient undergoing HSCT.

Exclusion Criteria

• Vitamin A hypersensitivity or allergy.
• Age less than 1 year at time of transplant.
• Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.
• Enteral feeding or medication intolerance.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin A	Vitamin A	Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.

Primary Outcome Measures

Name	Time	Method
Vitamin A Level	30 days after HSCT	Vitamin A level will be measured 30 days after HSCT.

Secondary Outcome Measures

Name	Time	Method
Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)	100 days after HSCT	Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States